Cleared Traditional

K840566 - BONE STAPLING FIXATION SYS

K840566 is an FDA 510(k) clearance for BONE STAPLING FIXATION SYS, manufactured by 3M Company. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K840566 · 3M Company · Orthopedic device
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Nov 1984
Decision
289d
Days
Class 2
Risk

K840566 is an FDA 510(k) clearance for the BONE STAPLING FIXATION SYS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on November 23, 1984 after a review of 289 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K840566

510(k) Number K840566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date November 23, 1984
Days to Decision 289 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 122d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDR Staple, Fixation, Bone

All 130
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K840566.
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445 · Kirschner Medical Corp. · Nov 1985
DAY STAPLE
K853267 · Protek, Inc. · Sep 1985
FIXATION STAPLE DRIVER/EXTRACTOR
K832884 · Warsaw Orthopedic, Inc. · Oct 1983
STAPLES DESIGNED FOR ARTHROSCOPIC SURG
K830455 · Instrument Makar, Inc. · Mar 1983
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943 · Howmedica Corp. · Oct 1982